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Novel Foods and novel food ingredients - Review of Regulation (EC) 258/97

Animal cloning and Novel Food

Cloning is a relatively new technique of asexual reproduction of animals producing near exact genetic copies of the animal cloned, i.e. without modification of genes.

Novel food is food which was not consumed in the EU to a significant degree before May 1997, i.e. before Regulation (EC) 258/97 entered into force. This is in particular to food produced using new techniques and technologies, such as nanomaterials.

Why are animal cloning and Novel Food linked?

At present, food from clones falls under the scope of the Novel Food Regulation and is thus subject to pre-market approval based on a safety risk assessment. Inter-institutional discussions on cloning started in 2009 in the context of the negotiations on a proposal streamlining the approval process of the 1997 Novel Food Regulation. No agreement could be reached between Member States and the European Parliament on any of the issues linked to cloning. The conciliation failed in March 2011. Following this failure, the European Parliament called upon the Commission to present a proposal on cloning based on an impact assessment.

Latest developments: New legislative proposals

As a result the Commission on 18 December 2013 adopted three proposals:

  1. Proposal for a Regulation of the European Parliament and of the Council on novel foods BG CS DA DE EL EN ES ET FI FR HR HU IT LT LV MT NL PL PT RO SK SL SV pdf.
    It revises the existing Novel Food Regulation with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.
  2. Two proposals addressing animal welfare and other ethical concerns related to the use of the cloning technique.

Tonio Borg's statement on the adoption of the proposals pdf

Press Release pdf

Press Memo pdf (questions and answers)

Background

Novel Food

Under the draft Regulation, novel food would be subject to a simpler, clearer and more efficient authorisation procedure fully centralised at EU level, which should enable safe and innovative food to be placed on the EU market faster without compromising a high level of public health.

Novel food refers to all food which were not consumed in the EU to a significant degree before May 1997, i.e. before the current Regulation entered into force and in particular to food produced using new techniques and technologies, such as nanomaterials.

Special provisions are also made for food which has not been marketed in the EU but which has a history of safe use in non-EU countries. This creates a more balanced system and a positive environment for trade.

Protecting innovation is also a feature of the draft law. Under the new system, in case of innovation supported by new scientific developments, the food company which submitted the application, may be given the authorisation to market the food for 5 years before it can be produced and marketed by others.

Cloning

Cloning is a relatively new technique of asexual reproduction of animals producing near exact genetic copies of the animal cloned, i.e. without modification of genes. Cloning animals means creating animals by using the genetic material from a cell from another animal. It is reproduction performed in a laboratory. The closest natural analogy to a clone is identical twins. As identical twins, clones and cell donor animals share exactly the same genetic inforamtion (DNA).

In practice the nucleus of normal body cell is transferred into an egg (oocyte) from another animal from which the nucleus has been removed. The manipulated oocyte is implanted into a surrogate mother who will give birth to the clone. The clone will eventually develop into an adult animal. Currently, cloning is used for research purposes in the EU. The proposals do not prevent this.

Links:

Novel Food

Cloning